Speculum

ABSTRACT

A speculum, comprising a handle portion including a proximal end, a distal end and at least one sidewall connecting the proximal end and the distal end and having a cavity in the sidewall thereof, a lower blade connected to the handle portion, an upper blade movably connected to the lower blade, the upper and lower blades being configured to move relative to one another between a closed state and an open state, and a lighting assembly comprising at least one light source and at least one energy storage device, said lighting assembly being at least partially disposed in the cavity in the sidewall of the handle portion.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/748,435, filed Jun. 24, 2015, which is a continuation of U.S.application Ser. No. 14/316,787, filed Jun. 26, 2014, which is acontinuation-in-part of U.S. application Ser. No. 13/241,136 filed Sep.22, 2011, entitled “DISPOSABLE SPECULUM HAVING LATERAL STABILIZINGMECHANISM,” currently pending, which claims the benefit of ProvisionalApplication No. 61/387,038 filed Sep. 28, 2010. All of theseapplications are incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to speculums.

Description of Related Art

A speculum is a medical instrument for dilating the opening of a bodycavity for medical examination. A vaginal speculum commonly used duringa gynecological examination or a surgical procedure is introduced into apatient's vagina to separate the vaginal walls, thus allowing theinternal genital organs to be examined. Metal, autoclavable duck-billspecula are conventionally used for gynecological examination andtreatment. These units, with exposed joints, sharp edges, and cold metalare universally disliked by patients. The hinged joints and blade edgesoften pinch, scrape, or otherwise traumatize the supporting tissues inthe area being examined. The conventional metallic specula blades aretypically opaque. Therefore, the only area available for inspection whena metallic speculum is in use is the open end, for cervical examination,and the vaginal wall areas between the blades.

In an attempt to eliminate some of the problems mentioned above, plasticspecula have been developed. Plastic specula, which are formed fromplastic or another lightweight and inexpensive material, are oftendesigned with a double-hinge. Although these double-hinge designssatisfactorily support the vertical stresses placed on the speculum,current designs allow for significant movement when exposed to lateralforces. Such lateral forces are common when vaginal muscles become tenseduring procedures which do not require anesthesia, and the resultinglateral movement is objectional to the physician because it can resultin speculum movement inside the vagina, or in the worst case speculumcollapse.

Sufficient lighting of the subject area for examination is another areaof difficulty, since typical specula are not equipped with illuminationdevices. Light must be directed from another source, often a goosenecklamp that can partially obstruct the view into the vagina. Head-mountedlights have been used as a partial solution to this problem, but suchhead-mounted lights are uncomfortable for the operator and cumbersomedue to the light cord. Lights built into the handle of existing speculagenerally project into a light pipe which follows up the center of thespeculum. Since this light and light pipe assembly occupy the center ofthe handle the speculum hinge mechanism must be offset to one side.However, such offsetting from the center of the speculum has theundesirable effect of increasing lateral movement resulting from stress.

SUMMARY

According to one embodiment of the present disclosure, a speculumincludes an upper blade, a lower blade, a link member, a handle portion,a curved portion, and a light source. The link member connects the upperblade and the lower blade to allow the upper blade and the lower bladeto move between an open state and a close state. The curved portionconnects the lower blade and the handle portion. The light source isdisposed on the curved portion.

According to another embodiment of the present disclosure, a speculumincludes an upper blade, a lower blade, a link member, a handle portion,and a light source. The link member connects the upper blade and thelower blade to allow the upper blade and the lower blade to move betweenan open state and a close state. The handle portion is connected to thelower blade. The light source is disposed on the junction of the lowerblade and the handle portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A and FIG. 1B show an embodiment of a vaginal speculum of thepresent disclosure. FIG. 1A is a perspective view of the vaginalspeculum. FIG. 1B is a rear view of the vaginal speculum.

FIG. 2 is a perspective view of an upper member of the vaginal speculumof FIG. 1A.

FIG. 3 is a plan view showing an interior side of the upper member ofthe vaginal speculum of FIG. 2 . The upper member includes an upperblade, a supporting structure, and an operating mechanism.

FIG. 4A and FIG. 4B are perspective views of a lower member of thevaginal speculum of FIG. 1A. FIG. 4A is a rear perspective view of thelower member. FIG. 4B is a front perspective view of the lower member.

FIG. 5 is a close-up plan view of the lower member of the vaginalspeculum of FIG. 4A and FIG. 4B. The lower member includes a lower bladeand a track for engaging a linear support member.

FIG. 6 is a close-up perspective view of the track of FIG. 5 .

FIG. 7 is a perspective view of a linear support member of the vaginalspeculum of FIG. 1A and FIG. 1B.

FIG. 8A and FIG. 8B show the upper member of FIG. 1A and FIG. 1B securedto the linear support member of FIG. 7 . FIG. 8A is a side view of theupper member secured to the linear support member. FIG. 8B is aperspective view of the upper member secured to the linear supportmember.

FIG. 9 is a perspective rear view of the linear support member of FIG. 7positioned within the track of the lower member of FIG. 6 .

FIG. 10A, FIG. 10B and FIG. 10C show an embodiment of a light source foruse with the vaginal speculum of FIG. 1A and FIG. 1B. FIG. 10A is aperspective view of the light source showing some of the outer and theinner components. FIG. 10B is a back view of the light source showinginner components. FIG. 10C is a side view of the light source showingsome of the outer components.

FIG. 11 shows an embodiment of a light guide and smoke evacuationchannel for use with the vaginal speculum of FIG. 1A and FIG. 1B havingthe light source of FIG. 10A.

FIG. 12 shows a rear perspective view of the lower member of the vaginalspeculum of FIG. 1 having the light source of FIG. 10A.

FIG. 13 is a perspective rear view of a speculum according to anotherembodiment of the present disclosure.

FIG. 14 is a perspective rear view of the lower member and the lightsource of FIG. 13 .

FIG. 15 is a sectional view taken along line 15 of FIG. 14 .

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Vaginal speculums having lateral stabilized support and operatingmechanisms are disclosed herein. The disclosed vaginal speculums arefabricated from plastic materials, and are designed to be for single-useand are fully disposable. Although the vaginal speculums disclosedherein are intended to be used by gynecologists, it is understood thatthe vaginal speculums may also be used for example, by primary carephysicians, geriatricians, urologists and nurse practitioners.

As used herein, the term “cross-contamination” refers to the passing ofbacteria or viruses indirectly from one patient to another through theuse of improper sterilization procedures, unclean instruments, orrecycling of products.

As used herein, the term “disposable” refers to a vaginal speculum ofthe present disclosure designed for short-term convenience, and intendedfor single-use. The disposable vaginal speculum therefore does not needto be sterilized after use, which reduces the cost of maintaining thevaginal speculum, and minimizes the risk of cross-contamination.

As used herein, the term “female internal genital organs” refers to thevulva, vagina and cervix.

As used herein, the term “gynecological examination” or “surgicalprocedure” refers to a medical procedure performed on a female patientto visualize, inspect, and/or remove a portion of the female internalgenital organs. Common gynecological procedures and surgeries include,but are not limited to, colposcopy, cervical cryosurgery, loopelectrosurgical excision procedure (LEEP) procedure, hysteroscopy,dilation and curettage (D&C), cervical biopsy, transcervical chorionicvillus sampling, endometrial ablation, endometrial biopsy, vaginalhysterectomy and PAP test.

The vaginal speculums disclosed herein can be used during variousmedical procedures, and more particularly are used for gynecologicalprocedures either in an office or a hospital setting.

As used herein, the term “elevational movement” refers to the verticalup-and-down movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “linear” refers to a straight line of material,for example, a straight line of plastic material. A linear supportmember refers to a support member of the present disclosure that is madefrom a straight line of plastic material, having no curves or angles.

As used herein, the term “angulational movement” refers to the angularup-and-down movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “lateral movement” refers to the sideways backand forth movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “open state” refers to the positioning of anupper blade and a lower blade of a vaginal speculum of the presentdisclosure at a spaced-apart distance. The open state may beaccomplished by elevating a support member that connects the upper bladeand the lower blade together, by angularly moving the upper bladerelative to the lower blade, or by a combination of both.

As used herein, the term “working space” refers to a space createdbetween an upper blade and a lower blade of a speculum of the presentdisclosure. In an embodiment, the working space is created for viewing,examining, and performing surgical procedures on female internal genitalorgans.

As used herein, the term “structural integrity” refers to a featureprovided by a vaginal speculum of the present disclosure prior to,during, and after use. An upper blade and a lower blade of the speculumare designed to withstand applied loads and transfer these applied loadsto various other components of the speculum, while maintaining thestructural integrity of the speculum.

As used herein, the term “fulcrum” refers to a support structure createdby engaging a support member and a support structure of a vaginalspeculum of the present disclosure. The created fulcrum results in theability for an upper blade of the vaginal speculum to angularly movewith relation to a lower blade of the vaginal speculum.

As shown in FIG. 1A and FIG. 1B, a disposable vaginal speculum 100 ofthe present disclosure includes an upper member 120, a linear supportmember 150, and a lower member 130 having a built-in light source 160.The linear support member 150 is engaged to both the upper member 120and the lower member 130, as will be described in detail below. Unlikemetallic speculums, which are not designed for single-use but insteadare meant to be re-used many times with sterilization occurring betweeneach use, the entire speculum 100 of the presently disclosed embodimentsis fabricated from one or more plastics or plastic composites,sterilized when manufactured or packaged, and sufficiently inexpensiveto be discarded after only one use. Sterilization of reusable speculacan be costly and time-consuming. More significantly, if sterilizationis not done properly, blood borne pathogens or other harmful biologicalagents from one patient can survive the sterilization process and betransmitted to another patient. Because the entire speculum 100 of thepresently disclosed embodiments is disposable, there is no need tosterilize the speculum 100 after each use, which greatly reduces thetime and cost associated with such sterilization procedures and preventscross-contamination. Exemplary plastic materials which may be used toconstruct the various components of the speculum 100 include, but arenot limited to, polypropylene, polyester, polyethylene, acrylic,polycarbonate, polyamide, polystyrene, and any composite of more thanone of these plastics.

In an embodiment, the upper member 120 and the lower member 130 arefabricated from plastic materials that are substantially rigid andcapable of transmitting light. For example, the upper member 120 and thelower member 130 may be molded from a colorless transparent plasticmaterial such as acrylic plastic or the like. Acrylic plastic isrelatively rigid, can be injection molded or extruded, and has excellentlight conductive properties most suitable for use with the speculum 100of the present disclosure. In an embodiment, the linear support member150 is fabricated from a different plastic material than the uppermember 120 and the lower member 130. The linear support member 150 isfabricated from a rigid, sturdy, plastic material that can handlevarious load patterns, as will be described in detail below. In anembodiment, the upper member 120 and the lower member 130 are fabricatedfrom a polycarbonate material. In an embodiment, the linear supportmember 150 is fabricated from a polyester material. In an embodiment,the linear support member 150 is fabricated from a polyamide material,for example, nylon.

As best illustrated in FIG. 2 , the disposable speculum 100 comprises anupper member 120 having an upper blade 122 that terminates in a hingeassembly 125. The hinge assembly 125 receives and transfers loads placedon the upper member 120 and the lower member 130 to various componentsof the speculum 100, as will be described in detail below. The hingeassembly 125 includes an operating mechanism 127 which extends out fromthe hinge assembly 125. As shown in the embodiments depicted in thefigures, the operating mechanism 127 is located on a left-side of theupper blade 122. In another embodiment, the operating mechanism 127 maybe located on a right-side of the upper blade 122. The unique design andlow profile of the hinge assembly 125 enable a user of the speculum 100to have a large unobstructed view of a patient during a gynecologicalprocedure. In an embodiment, the operating mechanism 127 extends out anddown from the upper blade 122 at an angle. Also, a working space 115created when the speculum 100 is in an open state (see FIG. 1B, thespeculum 100 is not shown entirely in the open state in the figures)provides exceptional instrument maneuverability to the user of thespeculum 100. The speculums known in the art often provide a limitedworking space with limited visibility due to a poorly designed hingeassembly.

As shown in FIG. 2 and FIG. 3 , the hinge assembly 125 comprises a pairof parallel support beams 129 spaced a distance apart. These parallelsupport beams 129 will interact with the support member 150 to preventhinge slippage when a lateral force is present. The operating mechanism127 interacts with an angulation arm 157 on the support member 150 whichallows a user of the speculum 100 to move the upper blade 122 at variousangles when pressure is applied to the operating mechanism 127 duringuse of the speculum 100. The operating mechanism 127 is formed with anopening 126 for which the angulation arm 157 of the linear supportmember 150 moves through and locks with. The upper blade 122 has athickness, a width and a curve, which prevents failure of the upperblade 122 with the application of pressure or stress, for example duringa gynecological procedure. In an embodiment, the upper blade 122 has arounded distal end.

FIG. 4A and FIG. 4B show the lower member 130 of the speculum 100. Thelower member 130 includes a lower blade 132 and a handle portion 134.The handle portion 134 includes a vertical track 137 for elevationalmovement of the linear support member 150, and a cavity 139 forpositioning of the built-in light source 160 (see FIG. 1A or FIG. 1B).In an embodiment, the track 137 is a carved-out space positioned at asingle side of the handle portion 134. On an outer surface of the handle134 at a distal end of the track 137, there are stop tabs 131. Thesestop tabs 131 encounter a locking tooth 159 on an elevation leg 155 ofthe linear support member 150 (see FIG. 7 ) and maintain the speculum100 in an open state at various, user-selected distances. Because thelight source cavity 139 is typically placed in the center of handle 134,the track 137 for support member 150 is ideally placed either to theleft or the right of the light source cavity 139. Such placement of thesupport track 137 will cause translation of the normal vertical stressplaced upon top member 120 into a lateral force. A typical speculum willsuffer lateral movement of the top blade as a result. This lateralmovement interferes with many physician procedures, can cause patientdiscomfort, and may lead to a structural failure of the speculum. Toeliminate this lateral movement a novel support structure 136 has beenadded so as to protrude slightly into the viewing area 115. This supportstructure 136 interacts with a hidden slot 191 in support member 150(see FIG. 7 ) to substantially eliminate lateral movement. The supportstructure 136 is shown on the right side of the lower member 130. In anembodiment, the support structure 136 and the hidden slot 191 arelocated on the right side of the speculum 100. In another embodiment,the support structure 136 and the hidden slot 191 are located on bothsides of speculum 100.

As shown in the embodiment depicted in FIG. 4B, the handle 134 has atleast one shaped surface so that a user of the speculum 100 may easilygrasp the handle 134. The lower blade 132 has a thickness, a width, anda curve which prevents failure of the blade 132 with the application ofpressure or stress. In an embodiment, the lower blade 132 has a roundeddistal end.

FIG. 5 shows a close-up plan view showing an interior surface 133 of thelower blade 132. The track 137 has a “T-shape,” with a long verticalsection represented by 136 a and a shorter horizontal sectionrepresented by 136 b for accepting the linear support member 150.

FIG. 6 shows a close-up perspective view of the track 137 in which thesupport member 150 rides in.

FIG. 7 in conjunction with FIG. 8A, FIG. 8B and FIG. 9 , show variousviews of the linear support member 150 of the vaginal speculum 100. Thelinear support member 150 has a proximal end 152, a distal end 156 andan elongated body 154 having a “T-shape.” The elongated body 154 rideswithin the track 137. Additionally, the support structure 136 rideswithin the hidden slot 191 to provide additional lateral support. Holes153 of the linear support member 150 attach with the hinge assembly 125of the upper member 120. Key holes 110 interact with the parallelsupport beams 129 of the hinge assembly 125 to prevent slippage andsubsequent failure of the hinge during lateral stresses. The angulationarm 157 and the elevation leg 155 both protrude from a lip 158 of theelongated body 154. The angulation arm 157 passes through the opening126 of the operating mechanism 127 of the hinge assembly 125 of theupper member 120 and is held in place with locking teeth on theangulation arm 157. The locking tooth 159 of the elevation leg 155 lockswith the stop tabs 131 on the outer surface of the handle 134.

During a gynecological examination or surgical procedure, it issometimes desirable to illuminate the working area so that a medicalprofessional performing the procedure can properly view the workingarea. Typical specula are not equipped with illumination devices, andnewer speculums that contain light sources generally generate unwantedheat, consume significant power, are tethered to a power source, andproject light in unwanted directions. The power consumed requires wiresto an external power supply which is cumbersome for a medicalpractitioner, creates a potential hazard to a patient, and is a sourceof cross-contamination, as the light source is not easily sterilizedbetween procedures. The unwanted directionality of light will not onlyilluminate the practitioners working space, but also will illuminate thepractitioner and impair the practitioner's vision.

Attempts to overcome the above shortcomings have been problematicthemselves. One known speculum includes a fiber bundle built into thespeculum and an external light source. While this overcomes the heatgeneration and light directionality problem, the problem forcross-contamination still exists. Another known speculum discloses alight bulb built into the speculum handle with a reflector also builtinto the handle. While this overcomes the problem of lightdirectionality, problems related to cross-contamination and heatgeneration still exist. Other speculums disclose a battery operatedhalogen light source built into the handle. This solves thecross-contamination problem, but does not solve the light directionalityproblem and heat problem.

FIG. 10A, FIG. 10B, and FIG. 10C, show an embodiment of the built-inlight source 160 that resides within the handle 134 of the disposable,plastic speculum 100. An outer housing 163 protects internal batteries166, a light emitting diode (LED) 164, and internal components of a tabswitch 165, which is removed to illuminate the LED 164 when illuminationis desired. The LED 164 may produce any desired level of intensity. Forexample, a resistance tab on the built-in light source 160 may be usedto control the intensity of light that the LED 164 can emit. The LED 164has a high power efficiency and consumes relatively little electricalpower with a long lifespan. The LED 164 solves the heat problem becausethe power efficiency of an LED is greatly superior to prior incandescentor laser solutions. The light output from the LED 164 is highlydirectional, emitting light only within about a twenty-degree path. Thisnarrow light path ensures that light is only projected onto the workingarea, and not directly into the practitioner's eyes. The LED 164 isenergy-efficient and can be powered by a single lightweight battery 166or a number of batteries 166. Because the light source 160 is built intothe handle 134 of the disposable speculum 100, the problem ofcross-contamination is eliminated. The built-in light source 160 alsoeliminates cumbersome and potentially dangerous wires extending from thespeculum 100 to an external power supply.

In an embodiment, the LED light source 164 is a white LED.

In an embodiment, single or multiple wavelength LED sources can besubstituted to choose a light wavelength that is uniquely suited tomaterials, chemicals, tissue, or tools used in current or futuregynecological procedures such that these materials, chemicals, tissue ortools will distinctly illuminate when such wavelengths are projected,thus aiding in the practitioner's ability to view and perform aprocedure, aiding in material property changes (such as epoxy hardeningor activating some other specific material property), altering the stateof tissue life, or serving as a contamination neutralizing agent.

In an embodiment, the LED light source 164 is a single wavelength lightemitting diode.

In an embodiment, the LED light source 164 is a multiple wavelengthlight emitting diode.

FIG. 11 shows an embodiment of a light guide 138 having a proximal end138 a and a distal end 138 b. The light guide 138 runs from a distal endof the cavity 139 to a distal end of the lower blade 132 on the interiorsurface 133 of the lower blade 132 (see FIG. 4A and FIG. 4B). Theproximal end 138 a of the light guide 138 will transfer light comingfrom the light source 160 through the light guide 138 and out of thedistal end 138 b. The light guide 138 is contoured to ride on theinterior surface 133 of the lower blade 132. The proximal end 138 a ofthe light guide 138 may include a lens that couples with the lightsource 160 contained in the cavity 139 of the handle 134.

In certain gynecological procedures, it is desirable to remove abnormalcells from the internal and external portions of the cervix. Also,certain gynecological procedures use instruments that produce smoke,which makes it difficult for a medical professional to see a workingspace during the procedure. Therefore, the use of an external vacuumsource during gynecological procedures is common. These external vacuumsources are cumbersome, difficult to manipulate during the procedure,and are a source of cross-contamination, since the vacuum is re-used formany patients.

Existing specula containing both a light guide and a smoke evacuationchannel have typically built the light guide into the lower bladethereof and the smoke evacuation channel into the upper blade thereof.This arrangement significantly detracts from the working space betweenthe two blades that is needed to perform vaginal or uterine procedures.Additionally, an external suction tube must be connected to the upperblade of these existing specula which further complicates and obstructsthe working area for the physician.

FIG. 11 in conjunction with FIG. 4A and FIG. 12 shows the lower member130 of the speculum 100 having a smoke vacuum channel 138 c and thelight guide 138 merged together and positioned within a sunken relief135 of the lower member 130 to create a compact structure. The combinedsmoke channel light guide consists of the light guide 138 with thechannel 138 c for smoke evacuation cut into the side of the light guide138 that comes in contact with the lower blade 132. A tunnel formed bythe channel 138 c is used as a smoke channel. The resulting compactstructure created by merging the smoke vacuum channel 138 c and thelight guide 138 allows for the working space of the speculum 100 to bemaximized. Additionally, an external suction tube may be connected tothe handle 134 of the speculum 100 at an opening 169 instead of at theupper blade 122 of the speculum 100. Connection of the external suctiontube to the lower handle 134 maintains a clear and unobstructed accessto the vaginal area for the physician. Smoke is drawn from the distalend 138 b of the light guide 138 through the channel 138 c that extendsunder the light guide 138 and out the bottom of the speculum handle 134where external suction tubing can be attached.

In an embodiment, debris is drawn from the distal end 138 b of the lightguide 138 through the channel 138 c that extends under the light guide138 and out the bottom of the speculum handle 134 where external suctiontubing can be attached.

In an embodiment, bodily fluids are drawn from the distal end 138 b ofthe light guide 138 through the channel 138 c that extends under thelight guide and out the bottom of the speculum handle 134 where externalsuction tubing can be attached.

The ability of the speculum 100 of the present disclosure to withstandapplied loads is a result of a combination of components of the speculum100, including, but not limited to, the geometry of the hinge assembly125, a support beam 128, the parallel support beams 129, the geometry ofthe upper blade 122 and the lower blade 132, the lateral supportstructure 136 and the hidden slot 191, and the interdependent loadingbetween the various components. In an embodiment, during use, pressureexerted on the operating mechanism 127 is transferred to the hingeassembly 125, the mechanical holes 153, and down the elongated body 154of the linear support member 150. As shown clearly in FIG. 3 and FIG. 8, the operating mechanism 127 is an extension of the hinge assembly 125,extending outwards and downwards at an angle. This extension design ofthe operating mechanism 127 imparts asymmetrical loads on the plasticlinear support member 150 and will create lateral movement on the distalend of the upper blade 122. To prevent lateral movement, the novelfeatures of the lateral support structure 136 and the hidden slot 191have been added. For example, the operating mechanism 127 is capable ofabsorbing some of the initial load that a user imparts on the speculum100, such that the load is felt asymmetrically at the two support holes153 of linear support member 150. These asymmetric loads placed on thelinear support member 150 are directed in both a downward and forwarddirection. The asymmetrical forward loads in turn result in a lateralforce on the elongated body 156 of the linear support member 150. In atypical speculum this lateral force will cause twisting of the elongatedbody of the linear support member thereof, and may cause unwantedmovement of the speculum blades or hinge failure. In this embodiment,the lateral support structure 136 and the hidden slot 191 absorb theasymmetrical forward forces and in turn substantially eliminate twistingof the elongated body 156 of the linear support member 150. Thisreduction in twisting load at the linear support member 150 reduces thetendency of the linear support member 150 to twist and permits the useof a plastic linear support member 150.

During use of the speculum 100, for example during a gynecologicalprocedure, the speculum 100 is inserted into a patient's vagina. Thevaginal walls in turn exert a pressure, or load, on the upper blade 122and the lower blade 132 of the speculum 100. The upper blade 122 and thelower blade 132 are capable of transferring this load to the supportmember 150 and the operating mechanism 127 because of the unique designof the lateral support structure 136 of the lower member 130 of thespeculum 100. The support structure 136 is capable of supporting thelateral load and distributes the vertical load equally down both thelinear support member 150 and the operating mechanism 127. This resultsin a great deal of holding power in a relatively small area withoutlateral top blade movement or top blade hinge failure.

The upper blade 122 and the lower blade 132 have a curved shape whichincreases the stiffness and strength of the blades. The stiffnessimparted on the curved blades enables the blades to support the appliedload along an entire length of the blades, without the need foradditional strengthening structures within the blades. The proximal end152 of the linear support member 150 and the parallel hidden slot 191and track 137 help prevent failure of the speculum 100 due to asymmetricloading on the blades that would cause the speculum 100 to twistrelative to the handle's 134 axis. The design of the speculum 100prevents twisting.

To operate the speculum 100 of the present disclosure during agynecological procedure, the upper blade 122 and the lower blade 132 areinserted into a vagina of a patient in a closed position. Closedposition can refer to complete closure, where the upper blade 122engages the lower blade 132, or can refer to partial closure, where theupper blade 122 and the lower blade 132 are partially separated.Thereupon, the linear support member 150 is moved upwardly by pressingon the elevation leg 155 until a desired degree of opening has beenattained. The locking tooth 159 of the elevation leg 155 locks with thestop tabs 131 on the outer surface of the handle 134. In an embodiment,when the desired degree of opening has been attained, the operating arm127 of the operating mechanism 125 is pressed spreading the upper blade122 and the lower blade 132 apart at an angle. The locking teeth on theangulation arm 157 lock at the opening 126 of the operating mechanism125, resulting in the speculum 100 being held in the open position. Thelight source 160 may be turned on to illuminate a surgical orexamination site. The pull tab 165 of the light source 160 is removed,resulting in the LED 164 illuminating. At the end of the procedure, thepull tab 165 may be inserted again to turn the LED 16 off. It is to beunderstood that a speculum 100 of the present disclosure may befabricated in various sizes, such that the proper sized speculum 100 canbe used for each patient. The speculum 100 may also be fabricated fromvarious strength plastic materials based on the desired use of thespeculum 100, as long as the structural integrity of the speculum 100remains. For example, for a routine PAP test, a lower strength speculum100 may be used as compared to a speculum 100 for use during vaginalhysterectomy.

In an embodiment, a speculum 100 is provided that includes an adjustableupper blade 122 and an adjustable lower blade 132 capable of expandingduring use of the speculum 100. Means for providing adjustable bladesinclude, but are not limited to, the use of laterally adjusting bladesthat expand the width of the blades and the use of longitudinallyadjustable blades that expand the length of the blades. The adjustableblades can be withdrawn partially or completely.

In an embodiment, a speculum 100 is provided that includes heating meansfor warming the upper blade 122 or the lower blade 132. The extra warmthprovided by the heating means enhances patient comfort and helps torelax the vaginal area. Means for heating the blades include, but arenot limited to, the use of heating coils within a hollowed out space ofthe blades, the use of powdered chemicals within a hollowed out space ofthe blades that are able to oxidize when exposed to air. In anembodiment, a speculum 100 includes heating coils on the upper blade 122and the lower blade 132 for bringing the temperature of the blades tobody temperature. In an embodiment, the heating coils can be powered bythe batteries 166 used in the built-in light source 160. In anembodiment, the heating coils can be powered by a different battery.

In an embodiment, a speculum 100 is provided that includes a distallymounted camera chip for real-time data capture and/or viewing of amedical procedure. The camera chip can store and/or capture data, andcommunicate with computer software to analyze the data. Data captured onthe camera chip can be analyzed for cellular and visual abnormalities ofthe vulva, vagina and cervix.

In an embodiment, a speculum 100 is provided that includes a pressuregauge, so that the pressure being applied from the speculum 100 to thevagina, or from the vagina to the speculum 100, can be monitored, aswell as the tightness of the vaginal canal. The pressure gauge may besimilar to a strain gauge and may be built into the speculum 100, forexample, at the hinge assembly 125.

In an embodiment, a speculum 100 is provided that includes a pH teststrip or a pH meter, for the fast and accurate determination of theacidity level of the vaginal canal being examined. The pH strip or pHmeter would be exposed to vaginal secretions to access the pH at anypoint in a gynecological or surgical procedure.

In an embodiment, a speculum 100 is provided that includes means forlubricating either or both of the upper blade 122 and the lower blade132. The lubricated blades make it easy for the speculum 100 to beinserted into a vaginal cavity of a patient, while providing a moistwork environment during a gynecological or surgical procedure.

In an embodiment, a body of the upper blade 122 and/or the lower blade132 has a hollowed-out space for passage of a lubricating jelly, as wellas holes at a surface for release of the lubricating jelly.

In an embodiment, the speculum 100 may come pre-packaged with an amountof lubricating jelly within the hollowed-out space of the blade. Thelubricating jelly is released through the holes present at the bladessurface, for example, by pushing a button on the handle 134. In anembodiment, the speculum 100 may include a port that can attach to aluer-lock syringe having the lubricating jelly, for passage of thelubricating jelly into the blades.

A method for dilating a vagina includes providing a disposable vaginalspeculum. The speculum has an upper member containing an upper blade, alower member containing a lower blade and including one or more lateralsupport beams that extend downward from an interior side of the lowerblade, and a linear support member that connects the upper member havingthe upper blade to the lower member containing the lower blade, suchthat the linear support member engages the lateral support beam or beamsand engages a rotational operating mechanism extending off the upperblade and a linear operating mechanism extending from the lower member.The linear support member is vertically moveable within a trackpositioned at a single side of a handle portion of the lower member. Themethod for dilating a vagina further includes inserting the upper bladeand the lower blade of the speculum into an opening of the vagina, andcreating a working space between the upper blade and the lower blade,thus dilating the vagina.

FIG. 13 is a perspective rear view of a speculum 100 according toanother embodiment of the present disclosure. FIG. 14 is a perspectiverear view of the lower member 130 and the light source 160 of FIG. 13 .FIG. 15 is a sectional view taken along line 15 of FIG. 14 . As shown inFIGS. 13-15 , the speculum 100 includes an upper member 120, a lowermember 130, a linear support member 150, and a light source 160. Theupper member 120 has an upper blade 122. The lower member 130 has alower blade 132 and a handle portion 134. The handle portion 134 isconnected to the lower blade 132. The linear support member 150 connectsthe upper member 120 and the lower member 130 to allow the upper blade122 and the lower blade 132 to move between an open state and a closestate. The light source 160 is disposed on the junction of the lowerblade 132 and the handle portion 134.

In some embodiments, the lower member 130 includes a curved portion C.The curved portion C connects the lower blade 132 and the handle portion134. The light source 160 is disposed on the curved portion C.

As shown in FIGS. 13-15 , a space is defined between the upper blade 122and the lower blade 132. The light source 160 is configured to providelight to the space. More specifically, the light source 160 includes atleast one lamp disposed on the curved portion C. The lamp has a lightoutput surface facing the space. The lamp is, for example, an LED 164.

Since the light source 160 is disposed on the curved portion C and isconfigured to directly provide light to the space, the light guide fortransferring light from the light source 160 to the space can beeliminated, resulting in a much brighter light. Furthermore, the lightsource 160 is built into the curved portion C so that the light source160 maintains a low profile and does not obstruct operator visibility.

As shown in FIGS. 13-15 , the light source 160 further includes at leastone energy storage device. The energy storage device is, for example, atleast one battery 166. The battery (or batteries) 166 is disposed on thecurved portion C and is configured to provide a supply of energy for theLED 164.

Conventional light sources for speculums are re-usable. Re-usable lightsources increase cross-contamination risks and are of significantconcern to hospitals. Unlike conventional light sources for speculums,the entire speculum 100 of FIGS. 13-15 including the light source 160 isdesigned for a single use. Specifically, since both the LED 164 and thebattery (or batteries) 166 are disposed on the curved portion C, wiresconnecting the LED 164 and the battery (or batteries) 166 can be shortand inexpensive to build. Furthermore, the light source 160 ispermanently fixed to the curved portion C. That is, the user cannoteasily separate the light source 160 from the curved portion C, andtherefore the user tends to discard the light source 160 along with thespeculum 100. In addition, the battery (or batteries) 166 of the lightsource 160 contains only enough energy for a single use of the speculum100, further discouraging the user from re-using the light source 160.

In some embodiments, the light source 160 includes a tab switch 165. Thetab switch 165 electrically separates the battery (or batteries) 166 andthe LED 164. The tab switch 165 is removable. The battery (or batteries)166 powers the LED 164 to illuminate when the user removes the tabswitch 165.

In some embodiments, the battery (or batteries) 166 is disposed betweenthe LED 164 and the handle portion 134 so that the battery (orbatteries) 166 does not obstruct the light provided by the LED 164.

Other details regarding the speculum 100 of FIGS. 13-15 are similar tothe speculum 100 of FIGS. 1-12 and therefore are not repeated here toavoid duplicity.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the following claims.

What is claimed is:
 1. A speculum comprising: a lower member comprising:a lower blade, and a handle comprising a sidewall defining a cavitytherein; an upper blade movable relative to the lower member between anopen state and a closed state; and a lighting assembly built into thecavity of the handle and comprising a light source, a power source, aremovable tab, and a housing at least partially enclosing the powersource, wherein the light source is spaced apart from the upper blade,wherein the housing comprises two oppositely arranged lateral sides thatextend parallel to the sidewall of the handle and comprises a rear sidethat extends between the lateral sides, wherein the housing issurrounded within the cavity along the lateral sides of the housing, andwherein the rear side of the housing is directly exposed along a rearface of the handle, and wherein the removable tab extends substantiallyperpendicularly through and with respect to the rear side of the housingand extends substantially perpendicularly and rearwardly with respect tothe rear face of the handle, and wherein the lighting assembly isconfigured to energize the light source when the removable tab isremoved.
 2. The speculum in accordance with claim 1, wherein the powersource comprises an energy storage device, and wherein the removable tabelectrically separates the energy storage device from the light source.3. The speculum in accordance with claim 2, wherein the removable tab islocated between the energy storage device and the light source, andwherein when the removable tab is removed, the lighting assembly isconfigured to electrically connect the energy storage device to thelight source to energize the light source.
 4. The speculum in accordancewith claim 2, wherein the energy storage device comprises a battery. 5.The speculum in accordance with claim 2, wherein the energy storagedevice comprises a single-use, non-rechargeable storage device.
 6. Thespeculum in accordance with claim 1, wherein the housing includes a slitopening and the removable tab extends through the slit opening.
 7. Thespeculum in accordance with claim 1, wherein the light source issupported by the housing.
 8. The speculum in accordance with claim 1,wherein the light source is one of a single wavelength light-emittingdiode (LED) and a multiple wavelength LED.
 9. The speculum in accordancewith claim 8, wherein the light source is a white LED.
 10. The speculumin accordance with claim 1, wherein the lighting assembly furthercomprises a light guide extending from the handle into an interior spaceof the lower blade.
 11. The speculum in accordance with claim 10,wherein the lower blade includes a recess and the light guide ispositioned within the recess.
 12. The speculum in accordance with claim10, wherein the light guide forms a smoke evacuation channel.
 13. Thespeculum in accordance with claim 1, wherein the upper and lower bladesare formed from a transparent material comprising one or more ofacrylic, polypropylene, polyester, polyethylene, polycarbonate,polyamide and polystyrene.
 14. The speculum in accordance with claim 1,wherein the speculum is configured to retract tissue.